Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
This office action is in response to the application filed on 06 January 2023. Claims 3-14, 16-29, 31-34, 36-49, 51-52, 54-67, 69-75, 78-87, 89-119, 121-181, 183-191, 193-227, 229-233, 237-252, 255-257 and 259-260 are cancelled. Claims 234-236, 253-254 are withdrawn. Currently, claims 1-2, 15, 30, 35, 50, 53, 68, 76-77, 88, 120, 182, 192, 228, 258, 234-236 and 253-254 are pending.
Priority
The instant application is a 371 National Phase Application of PCT/US2021/040714, filed on 7 July 2021, which claims domestic benefit of US provisional Application No. 63/048,910, filed on 7 July 2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06 September 2023 and 13 January 2026 was filed after the mailing date of the application on 06 January 2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Application’s election without traverse of Group I claims, drawn to compounds of formula (I-a), (I-b), (II), (XII), (III), (IV), (V), (VI), (VII), (VIII), (IX), (X), (XI), (XIII), (XVIII), (XX), (XXIII), (XIV), (XV), (XVI), (XVII), (XIX), (XXI), (XXII), (XXIV), (XXV), (XXVI) which reads upon claims 1-2, 15, 30, 35, 50, 53, 68, 76-77, 88, 120, 182, 192, 228, and 258 in the reply filed on 13 January 2026 is acknowledged. Applicant’s election without traverse of the compound from claim 182 (see below), reading on claims 1, 2, 15, 35, 50, 182, 228, and 258, in the reply filed on 13 January 2026 is also acknowledged.
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Applicant’s election of the compound of formula (1), an adjuvant formulation comprising the compound of formula (1) and a carrier diluent, or excipient as a species of adjuvant formulation is acknowledged.
Applicant’s election of viral infection as a species of disease is acknowledged.
The elected species was searched and found to be free of the prior art.
The search was expanded to the full scope of the claims. The closest match is a structure described by Fisher et al. (Farnesene dimers and/or farnesane dimers and compositions thereof, US 8,669,403 B2, 2014), described as “dehydrosqualene or (6E, 11E, 18E)-2, 6, 19, 23-tetramethyl-10,15-dimethylenetetracosa-2, 6, 11, 18, 22-pentaene”, as seen below (Preparation of dehydrosqualene from Farnesene, column 35, Example 3):
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No examples of eligible structures, before the priority date, beyond acyclic dehydrosqualene were identified.
Claims 1-2, 15, 35, 50, 182, 228, and 258 encompass the elected species and will be examined.
Claims 30, 53, 68, 76-77, 88, 120, and 192 do not encompass the elected species and are withdrawn in the interest of compact patent prosecution.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 and 258 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Fisher et al. (Farnesene dimers and/or farnesane dimers and compositions thereof, US 8,669,403 B2, 2014).
Fisher teaches dehydrosqualene (Preparation of dehydrosqualene from Farnesene, column 35, Example 3), synthesized from the palladium catalyzed coupling of Farnesene in one step. Although there is a structural difference between the elected species, containing a mono-unsaturated carbocycle with a pendant methanol, compared to dehydrosqualene with an acylic diene, the Examiner notes that instant claims 1-2 and 258 encompass dehydrosqualene, and therefore are anticipated by Fisher et al.
Allowable Subject Matter
Claims 15, 35, 50, 182 and 228 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: elected species formula (1), as recited in claims 15, 35, 50, 182 and 228, were not taught in the prior art in a 100% embodiment.
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The closest match is a structure described by Fisher et al. (Farnesene dimers and/or farnesane dimers and compositions thereof, US 8,669,403 B2, 2014), described as “dehydrosqualene or (6E, 11E, 18E)-2, 6, 19, 23-tetramethyl-10,15-dimethylenetetracosa-2, 6, 11, 18, 22-pentaene”, as seen below (Preparation of dehydrosqualene from Farnesene, column 35, Example 3):
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No examples of eligible structures beyond acyclic dehydrosqualene were identified.
Summary
Claims 15, 35, 50, 182 and 228 are objected to.
Claims 30, 53, 68, 76-77, 88, 120, 192, 234-236 and 253-254 are withdrawn.
Claims 1-2 and 258 are rejected under 35 U.S.C. 102 and are not allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Allen Chao whose telephone number is (571)272-7001. The examiner can normally be reached Monday - Friday 0700-1300.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALLEN CHAO/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622